Endostream Medical has announced that it has officially received European Union (EU) Medical Device Regulation (MDR) certification for its Nautilus intrasaccular system—a novel device intended for the treatment of brain aneurysms.
The company revealed this news via a LinkedIn post on 17 November.
“This is an important step for us as we work to ensure our products meet the highest standards of safety and effectiveness,” the post states. “A huge thank you to our incredible team and partners who made this possible.”
In early 2023, Endostream announced enrolment of the first patient in its TORNADO-US clinical study evaluating the Nautilus system in the USA. In addition, in March last year, researchers published four-year follow-up data from first-in-human experiences with the device in patients with unruptured intracranial aneurysms.
